A great problem in patient therapy is that it is often not possible to check how precisely the patient is sticking to the physician's prescriptions (“compliance”), i.e. whether and when he is taking his medicaments or, by way of example, is determining his blood sugar or how often and for how long he performs the exercises which he has been instructed to do. This information is extremely important, however, if it is necessary to assess the merit of a form of therapy or, by way of example, the effectiveness of a new medicament. Thus, when introducing new medicaments, for example, clinical studies are prescribed which prove a 10 to 20% better action as compared with an existing preparation or a placebo. This requires—on account of the high variability of the measured values—very large numbers of participants. The pharmaceutical industry assumes that 30 to 40% of the variability of the measured values can be attributed to a lack of standardization of boundary conditions: medicaments are not taken, or are not taken punctually, measured values are collected at different times and/or in a wide variety of ways etc. A similar situation applies to studies for assessing therapy results (“outcome analysis”) if it is not known how precisely the individual patients have stuck to their instructions. Finally, a comparable problem also arises with patients who have been given novel forms of telemedical care.
To date, the lack of standardization has been compensated for by increasing the number of subjects under test, which is time-consuming and cost-intensive. Such studies are still predominantly paper-based even today, i.e. questionnaires and/or survey sheets are filled in, collected and finally evaluated centrally. The correctness of the details can usually be checked—if at all—only in the form of plausibility checks.
The problems mentioned above have also not been able to be solved by a piece of equipment for recording values relating to state of health, as described in DE 196 14 255 C1. This merely involves the patient carrying around a mobile piece of equipment into which he enters respective data about medicaments taken, state of health etc. Whether a patient has actually been to and used a particular piece of therapy equipment, and if so, for what length of time, or whether or not he has taken the tablets, can be assessed with this test equipment only in the case of patients who are very careful, however. If the patient takes the tablets without using his equipment, this cannot be detected. A crucial factor, however, is that this merely involves a patient entering his data into a piece of recording equipment which he has. When patient actions are recorded automatically, however, a large amount of equipment and devices can be used which are not associated with the patient personally and which therefore also have no knowledge at all about who is using them.
The same also applies to an equipment system intended to be used in DE 100 54 960 A1 for examining the state of a patient and his readiness to cooperate and/or to prepare for therapy. This document merely involves access authorization for assessing the patient file, which requires user identification. In this arrangement, the equipment being used knows the particular person using it, which is not currently the case with real examinations of compliance.